Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 3 July 2020 the EMA published revision 8 of the guidance for sponsors.This guidance covers the information and procedures applicable to orphan designated products:
- incentives
- annual reports
- transfer of sponsorship
- change of sponsor’s name or address
- amendment of designated condition
- marketing authorisation application
- review of the maintenance of orphan medicinal product designation at the time of marketing authorisation application
- review of the maintenance of orphan medicinal product designation at the time of extending the therapeutic indication post-authorisation
- withdrawal of orphan designation
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